如何設(shè)定醫(yī)療器械臨床試驗的目的？

test4

　　為貫徹落實中共中央辦公廳、國務(wù)院辦公廳關(guān)于深化審評審批制度改革鼓勵藥品醫(yī)療器械創(chuàng)新的意見，加強醫(yī)療器械產(chǎn)品注冊工作的管理，進一步提高注冊審查質(zhì)量，鼓勵醫(yī)療器械研發(fā)創(chuàng)新，國家食品藥品監(jiān)督管理總局組織制定了醫(yī)療器械臨床試驗設(shè)計指導(dǎo)原則。

　　依據(jù)醫(yī)療器械臨床試驗設(shè)計指導(dǎo)原則的相關(guān)規(guī)定，臨床試驗需設(shè)定明確、具體的試驗?zāi)康�。申請人可綜合分析試驗器械特征、非臨床研究情況、已在中國境內(nèi)上市同類產(chǎn)品的臨床數(shù)據(jù)等因素，設(shè)定臨床試驗?zāi)康�。臨床試驗?zāi)康臎Q定了臨床試驗各設(shè)計要素，包括主要評價指標(biāo)、試驗設(shè)計類型、對照試驗的比較類型等，進而影響臨床試驗樣本量。

　　一、當(dāng)通過臨床試驗確認試驗器械在其預(yù)期用途下的安全有效性時，若更關(guān)注試驗器械的療效是否可滿足臨床使用的需要，其臨床試驗?zāi)康目稍O(shè)定為確認試驗器械的有效性是否優(yōu)于或等效于或非劣于已上市同類產(chǎn)品，同時確認試驗器械的安全性。此時，臨床試驗的主要評價指標(biāo)為有效性指標(biāo)。

　　二、當(dāng)通過臨床試驗確認試驗器械在其預(yù)期用途下的安全有效性時，若更關(guān)注試驗器械的安全性是否可滿足臨床使用的需要，其臨床試驗?zāi)康目稍O(shè)定為確認試驗器械的安全性是否優(yōu)于或等效于或非劣于已上市同類產(chǎn)品，同時確認試驗器械的有效性。此時，臨床試驗的主要評價指標(biāo)為安全性指標(biāo)，以ru房植入體為例，臨床試驗通常選擇并發(fā)癥發(fā)生率（如包膜攣縮率、植入體破裂率）作為主要評價指標(biāo)。

　　三、對于已上市產(chǎn)品增加適應(yīng)癥的情形，臨床試驗?zāi)康目稍O(shè)定為確認試驗器械對新增適應(yīng)癥的安全有效性。例如，止血類產(chǎn)品在已批準(zhǔn)適用范圍（如普通外科、婦產(chǎn)科）的基礎(chǔ)上，增加眼科、神經(jīng)外科、泌尿外科使用的適應(yīng)癥。

　　四、當(dāng)已上市器械適用人群發(fā)生變化時，臨床試驗?zāi)康目稍O(shè)定為確認試驗器械對新增適用人群的安全有效性。例如膜式氧合器產(chǎn)品，在原批準(zhǔn)適用范圍的基礎(chǔ)上新增體重小于或等于10千克的適用人群；又如治療類呼吸機在已批準(zhǔn)的適用于成ren的基礎(chǔ)上新增適用于兒童的適用范圍。

　　五、當(dāng)已上市器械發(fā)生重大設(shè)計變更時，可根據(jù)變更涉及的范圍設(shè)定試驗?zāi)康�。例如冠狀動脈藥物洗脫支架平臺花紋設(shè)計發(fā)生改變時，臨床試驗?zāi)康目稍O(shè)定為確認變化部分對于產(chǎn)品安全有效性的影響。

　　六、當(dāng)已上市器械的使用環(huán)境或使用方法發(fā)生重大改變時，試驗?zāi)康目稍O(shè)定為確認產(chǎn)品在特定使用環(huán)境和使用方法下的安全有效性。例如：已上市的植入式心臟起搏器通常不能兼容核磁共振檢查，如申請兼容核磁共振檢查，其臨床試驗?zāi)康目稍O(shè)置為對兼容核磁共振檢查相關(guān)的安全有效性進行確認。

tuv封之追憶

希望大家踴躍發(fā)言，我頂先













揚子空調(diào)維修門店
火王燃氣灶維修
北京燃氣灶維修電話
維修揚子空調(diào)漏水
揚子空調(diào)售后維修
南寧燃氣灶維修
西門子燃氣灶維修電話
櫻花抽油煙機售后電話
廈門修空調(diào)電話
太原空調(diào)維修公司
格蘭仕空調(diào)維修收費
長沙燃氣灶維修
老板燃氣灶維修電話
松下空調(diào)清洗
太原修空調(diào)電話
蘭州抽油煙機維修
廈門空調(diào)維修公司
三亞修空調(diào)多少錢
科恩抽油煙機售后電話
廈門抽油煙機維修

tuv封之追憶

不錯,頂?shù)娜瞬欢喟。�快點繼續(xù)













格蘭仕空調(diào)清洗服務(wù)
私人維修揚子空調(diào)
太原上門維修空調(diào)
揚子空調(diào)內(nèi)機漏水維修
揚子空調(diào)不開機維修
海爾燃氣灶售后維修
太原抽油煙機上門維修電話
立式松下空調(diào)維修
長沙燃氣灶維修電話
北京燃氣灶維修
帥康燃氣灶維修
美的燃氣灶維修電話
格蘭仕空調(diào)內(nèi)機漏水維修
成都抽油煙機維修
格蘭仕空調(diào)外機維修
揚子空調(diào)外機維修
揚子空調(diào)維修怎么收費
松下空調(diào)移機
三亞空調(diào)移機
揚子空調(diào)異地維修

蘿莉uu網(wǎng)32

國外uu,國產(chǎn)uu最新地址開放注冊了,網(wǎng)站難找


iujlb03.com

uu論壇63

國外uu,國產(chǎn)uu最新地址開放注冊了,網(wǎng)站難找


iujlb04.com

澳門生活網(wǎng)b

真的很有用，謝謝啦！













淘客機器人、淘客返利機器人、淘寶客機器人 聯(lián)系客服QQ：4000017854

香港社區(qū)網(wǎng)

謝謝啦，辛苦啦。感謝感謝!

ohnfb

http://www.longyin.net/thread-3797247-1-2.html
http://www.longyin.net/thread-3797249-1-2.html
http://www.longyin.net/thread-3797252-1-2.html
http://www.longyin.net/thread-3797254-1-2.html
http://www.longyin.net/thread-3797256-1-2.html
http://www.longyin.net/thread-3797258-1-2.html
http://www.longyin.net/thread-3797260-1-2.html
http://www.longyin.net/thread-3797262-1-2.html
http://www.longyin.net/thread-3797264-1-2.html
http://www.longyin.net/thread-3797267-1-2.html
http://www.longyin.net/thread-3797270-1-2.html
http://www.longyin.net/thread-3797272-1-2.html
http://www.longyin.net/thread-3797274-1-2.html
http://www.longyin.net/thread-3797276-1-2.html
http://www.longyin.net/thread-3797278-1-2.html
http://www.longyin.net/thread-3797280-1-2.html
http://www.longyin.net/thread-3797282-1-2.html
http://www.longyin.net/thread-3797284-1-2.html
http://www.longyin.net/thread-3797286-1-2.html
http://www.longyin.net/thread-3797288-1-2.html
http://www.longyin.net/thread-3797290-1-2.html
http://www.longyin.net/thread-3797292-1-2.html
http://www.longyin.net/thread-3797294-1-2.html
http://www.longyin.net/thread-3797296-1-2.html
http://www.longyin.net/thread-3797298-1-2.html
http://www.longyin.net/thread-3797300-1-2.html
http://www.longyin.net/thread-3797302-1-2.html
http://www.longyin.net/thread-3797304-1-2.html
http://www.longyin.net/thread-3797306-1-2.html
http://www.longyin.net/thread-3797308-1-2.html
http://www.longyin.net/thread-3797310-1-2.html
http://www.longyin.net/thread-3797312-1-2.html
http://www.longyin.net/thread-3797314-1-2.html
http://www.longyin.net/thread-3797316-1-2.html
http://www.longyin.net/thread-3797318-1-2.html
http://www.longyin.net/thread-3797320-1-2.html
http://www.longyin.net/thread-3797322-1-2.html
http://www.longyin.net/thread-3797325-1-2.html
http://www.longyin.net/thread-3797327-1-2.html
http://www.longyin.net/thread-3797329-1-2.html
http://www.longyin.net/thread-3797331-1-1.html
http://www.longyin.net/thread-3797333-1-1.html
http://www.longyin.net/thread-3797335-1-1.html
http://www.longyin.net/thread-3797337-1-1.html
http://www.longyin.net/thread-3797338-1-1.html
http://www.longyin.net/thread-3797341-1-1.html
http://www.longyin.net/thread-3797343-1-1.html
http://www.longyin.net/thread-3797345-1-1.html
http://www.longyin.net/thread-3797348-1-1.html
http://www.longyin.net/thread-3797350-1-1.html
http://www.longyin.net/thread-3797352-1-1.html
http://www.longyin.net/thread-3797354-1-1.html
http://www.longyin.net/thread-3797356-1-1.html
http://www.longyin.net/thread-3797358-1-1.html
http://www.longyin.net/thread-3797360-1-1.html
http://www.longyin.net/thread-3797362-1-1.html
http://www.longyin.net/thread-3797364-1-1.html
http://www.longyin.net/thread-3797366-1-1.html
http://www.longyin.net/thread-3797368-1-1.html
http://www.longyin.net/thread-3797370-1-1.html
http://www.longyin.net/thread-3797372-1-1.html
http://www.longyin.net/thread-3797374-1-1.html
http://www.longyin.net/thread-3797376-1-1.html
http://www.longyin.net/thread-3797377-1-1.html
http://www.longyin.net/thread-3797379-1-1.html
http://www.longyin.net/thread-3797381-1-1.html
http://www.longyin.net/thread-3797383-1-1.html
http://www.longyin.net/thread-3797385-1-1.html
http://www.longyin.net/thread-3797387-1-1.html
http://www.longyin.net/thread-3797390-1-1.html
http://www.longyin.net/thread-3797392-1-1.html
http://www.longyin.net/thread-3797394-1-1.html
http://www.longyin.net/thread-3797396-1-1.html
http://www.longyin.net/thread-3797398-1-1.html
http://www.longyin.net/thread-3797400-1-1.html
http://www.longyin.net/thread-3797402-1-1.html
http://www.longyin.net/thread-3797404-1-1.html
http://www.longyin.net/thread-3797406-1-1.html
http://www.longyin.net/thread-3797408-1-1.html
http://www.longyin.net/thread-3797410-1-1.html

gvgwe

http://www.longyin.net/thread-3798397-1-4.html
http://www.longyin.net/thread-3798398-1-4.html
http://www.longyin.net/thread-3798399-1-4.html
http://www.longyin.net/thread-3798400-1-4.html
http://www.longyin.net/thread-3798401-1-4.html
http://www.longyin.net/thread-3798402-1-4.html
http://www.longyin.net/thread-3798403-1-4.html
http://www.longyin.net/thread-3798404-1-4.html
http://www.longyin.net/thread-3798405-1-4.html
http://www.longyin.net/thread-3798406-1-4.html
http://www.longyin.net/thread-3798407-1-4.html
http://www.longyin.net/thread-3798408-1-4.html
http://www.longyin.net/thread-3798409-1-4.html
http://www.longyin.net/thread-3798494-1-4.html
http://www.longyin.net/thread-3798495-1-4.html
http://www.longyin.net/thread-3798496-1-4.html
http://www.longyin.net/thread-3798497-1-4.html
http://www.longyin.net/thread-3798498-1-4.html
http://www.longyin.net/thread-3798499-1-4.html
http://www.longyin.net/thread-3798500-1-4.html
http://www.longyin.net/thread-3798501-1-4.html
http://www.longyin.net/thread-3798503-1-4.html
http://www.longyin.net/thread-3798505-1-4.html
http://www.longyin.net/thread-3798507-1-4.html
http://www.longyin.net/thread-3798509-1-4.html
http://www.longyin.net/thread-3798511-1-4.html
http://www.longyin.net/thread-3798513-1-4.html
http://www.longyin.net/thread-3798515-1-4.html
http://www.longyin.net/thread-3798518-1-4.html
http://www.longyin.net/thread-3798520-1-4.html
http://www.longyin.net/thread-3798522-1-4.html
http://www.longyin.net/thread-3798524-1-4.html
http://www.longyin.net/thread-3798526-1-4.html
http://www.longyin.net/thread-3798528-1-4.html
http://www.longyin.net/thread-3798530-1-4.html
http://www.longyin.net/thread-3798532-1-4.html
http://www.longyin.net/thread-3798534-1-4.html
http://www.longyin.net/thread-3798536-1-4.html
http://www.longyin.net/thread-3798538-1-4.html
http://www.longyin.net/thread-3798540-1-4.html
http://www.longyin.net/thread-3798542-1-3.html
http://www.longyin.net/thread-3798544-1-3.html
http://www.longyin.net/thread-3798546-1-3.html
http://www.longyin.net/thread-3798548-1-3.html
http://www.longyin.net/thread-3798550-1-3.html
http://www.longyin.net/thread-3798552-1-3.html
http://www.longyin.net/thread-3798554-1-3.html
http://www.longyin.net/thread-3798556-1-3.html
http://www.longyin.net/thread-3798558-1-3.html
http://www.longyin.net/thread-3798560-1-3.html
http://www.longyin.net/thread-3798562-1-3.html
http://www.longyin.net/thread-3798564-1-3.html
http://www.longyin.net/thread-3798566-1-3.html
http://www.longyin.net/thread-3798568-1-3.html
http://www.longyin.net/thread-3798570-1-3.html
http://www.longyin.net/thread-3798572-1-3.html
http://www.longyin.net/thread-3798574-1-3.html
http://www.longyin.net/thread-3798576-1-3.html
http://www.longyin.net/thread-3798578-1-3.html
http://www.longyin.net/thread-3798581-1-3.html
http://www.longyin.net/thread-3798583-1-3.html
http://www.longyin.net/thread-3798585-1-3.html
http://www.longyin.net/thread-3798587-1-3.html
http://www.longyin.net/thread-3798589-1-3.html
http://www.longyin.net/thread-3798591-1-3.html
http://www.longyin.net/thread-3798593-1-3.html
http://www.longyin.net/thread-3798595-1-3.html
http://www.longyin.net/thread-3798597-1-3.html
http://www.longyin.net/thread-3798599-1-3.html
http://www.longyin.net/thread-3798601-1-3.html
http://www.longyin.net/thread-3798603-1-3.html
http://www.longyin.net/thread-3798606-1-3.html
http://www.longyin.net/thread-3798608-1-3.html
http://www.longyin.net/thread-3798610-1-3.html
http://www.longyin.net/thread-3798612-1-3.html
http://www.longyin.net/thread-3798614-1-3.html
http://www.longyin.net/thread-3798616-1-3.html
http://www.longyin.net/thread-3798618-1-3.html
http://www.longyin.net/thread-3798620-1-3.html
http://www.longyin.net/thread-3798622-1-3.html
http://www.longyin.net/thread-3798624-1-2.html
http://www.longyin.net/thread-3798626-1-2.html
http://www.longyin.net/thread-3798628-1-2.html
http://www.longyin.net/thread-3798630-1-2.html
http://www.longyin.net/thread-3798632-1-2.html
http://www.longyin.net/thread-3798634-1-2.html
http://www.longyin.net/thread-3798636-1-2.html
http://www.longyin.net/thread-3798638-1-2.html
http://www.longyin.net/thread-3798641-1-2.html
http://www.longyin.net/thread-3798643-1-2.html
http://www.longyin.net/thread-3798645-1-2.html
http://www.longyin.net/thread-3798647-1-2.html
http://www.longyin.net/thread-3798650-1-2.html
http://www.longyin.net/thread-3798652-1-2.html
http://www.longyin.net/thread-3798654-1-2.html
http://www.longyin.net/thread-3798656-1-2.html
http://www.longyin.net/thread-3798658-1-2.html
http://www.longyin.net/thread-3798660-1-2.html
http://www.longyin.net/thread-3798662-1-2.html
http://www.longyin.net/thread-3798664-1-2.html
http://www.longyin.net/thread-3798666-1-2.html
http://www.longyin.net/thread-3798668-1-2.html
http://www.longyin.net/thread-3798670-1-2.html
http://www.longyin.net/thread-3798672-1-2.html
http://www.longyin.net/thread-3798674-1-2.html
http://www.longyin.net/thread-3798676-1-2.html
http://www.longyin.net/thread-3798678-1-2.html
http://www.longyin.net/thread-3798681-1-2.html
http://www.longyin.net/thread-3798683-1-2.html
http://www.longyin.net/thread-3798685-1-2.html
http://www.longyin.net/thread-3798687-1-2.html
http://www.longyin.net/thread-3798689-1-2.html
http://www.longyin.net/thread-3798691-1-2.html
http://www.longyin.net/thread-3798693-1-2.html
http://www.longyin.net/thread-3798695-1-2.html
http://www.longyin.net/thread-3798697-1-2.html
http://www.longyin.net/thread-3798699-1-2.html
http://www.longyin.net/thread-3798701-1-2.html
http://www.longyin.net/thread-3798703-1-2.html
http://www.longyin.net/thread-3798704-1-2.html
http://www.longyin.net/thread-3798705-1-1.html
http://www.longyin.net/thread-3798707-1-1.html
http://www.longyin.net/thread-3798709-1-1.html
http://www.longyin.net/thread-3798710-1-1.html
http://www.longyin.net/thread-3798711-1-1.html
http://www.longyin.net/thread-3798712-1-1.html
http://www.longyin.net/thread-3798713-1-1.html
http://www.longyin.net/thread-3798714-1-1.html
http://www.longyin.net/thread-3798715-1-1.html
http://www.longyin.net/thread-3798716-1-1.html
http://www.longyin.net/thread-3798717-1-1.html
http://www.longyin.net/thread-3798718-1-1.html
http://www.longyin.net/thread-3798719-1-1.html
http://www.longyin.net/thread-3798720-1-1.html
http://www.longyin.net/thread-3798721-1-1.html
http://www.longyin.net/thread-3798722-1-1.html
http://www.longyin.net/thread-3798723-1-1.html
http://www.longyin.net/thread-3798724-1-1.html
http://www.longyin.net/thread-3798725-1-1.html
http://www.longyin.net/thread-3798726-1-1.html
http://www.longyin.net/thread-3798728-1-1.html
http://www.longyin.net/thread-3798731-1-1.html
http://www.longyin.net/thread-3798732-1-1.html
http://www.longyin.net/thread-3798733-1-1.html
http://www.longyin.net/thread-3798734-1-1.html
http://www.longyin.net/thread-3798735-1-1.html
http://www.longyin.net/thread-3798736-1-1.html
http://www.longyin.net/thread-3798737-1-1.html
http://www.longyin.net/thread-3798738-1-1.html
http://www.longyin.net/thread-3798739-1-1.html
http://www.longyin.net/thread-3798740-1-1.html
http://www.longyin.net/thread-3798741-1-1.html
http://www.longyin.net/thread-3798742-1-1.html
http://www.longyin.net/thread-3798743-1-1.html
http://www.longyin.net/thread-3798744-1-1.html
http://www.longyin.net/thread-3798745-1-1.html
http://www.longyin.net/thread-3798746-1-1.html
http://www.longyin.net/thread-3798747-1-1.html
http://www.longyin.net/thread-3798748-1-1.html
http://www.longyin.net/thread-3798749-1-1.html

ohnfb

http://www.yjsqsn.com/
http://www.zqxszx.com/
http://www.zqxszx.com/news/
http://www.zqxszx.com/
http://www.zqxszx.com/zhishi/
http://www.zqxszx.com/ask/
http://www.zqxszx.com/lianxi/
http://www.yjsqsn.com/bazisuanming/3390.html
http://www.yjsqsn.com/bazisuanming/3391.html
http://www.zqxszx.com/fuwu/306.html
http://www.zqxszx.com/fuwu/307.html
http://www.zifeiyuseo.com/